The Ministry of Health and Family Welfare on 24th August 2022, published the Drugs (Seventh Amendment) Rules, 2022 to further amend the Drugs Rules, 1945.
The amendment is brought under rule 75 which deals with Form of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C and X in which a new sub-rule 3A has been notified as follows:
The application for grant or renewal of licence to manufacture for sale or for distribution of drugs in (Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs), and the application for grant of permission to manufacture new drug for sale or distribution under rule 80 of the New Drugs and Clinical Trials Rules, 2019 or rule 122B of these rules, as the case may be, shall be made simultaneously.”
Further sub-rule 6 has been subtitled as follows:
Where an application under this rule is for the manufacture of drug formulations falling under the purview of new drug under rule 80 of the New Drugs and Clinical Trials Rules, 2019 or rule 122B, the licence to manufacture for sale or distribution of the drugs shall be granted after approval of the drug as new drug.
Rule 122B deals with Application for approval to manufacture new drug and rule 80 of the New Drugs and Clinical Trials Rules, 2019 deals with Application for permission to manufacture new drug for sale or distribution.
